以磺丁基醚-β-环糊精为渗透活性物质的盐酸氨溴索渗透泵片的制备

Preparation of osmotic pump tablets of ambroxol hydrochloride using sulfobutylether-β-cyclodextrin as an osmotically active substance

目的:以新型辅料磺丁基醚-β-环糊精(SBE-β-CD)作为渗透活性物质制备盐酸氨溴索渗透泵片,并对其释药机制进行初步探讨。方法:考察不同的渗透压活性物质对药物释放的影响,并通过正交设计试验确定了最优处方。结果:SBE-β-CD与常用的渗透压活性物质相比,具有显著优越性,制备的渗透泵片体外释药速率稳定,符合零级释药方程,且12 h累积释药率达到85%以上。结论:SBE-β-CD可以作为一种新型渗透活性物质,且制备的盐酸氨溴索渗透泵片是以渗透泵为主要的释药机制。

Objective： To prepare osmotic pump tablets of ambroxol hydrochloride using sulfobutylether-β-cyclodextrin as an osmotically active substance,and to investigate the mechanisms of drug release from the osmotic pump tablets.Methods： Influence of different osmotically active substances on drug release was studied.The optimal formulation was selected by orthogonal experiment.Results： Compared to general osmotically active substances,SBE-β-CD had marked superiority.The release of ambroxol hydrochloride was stable,and accorded with zero order release.The cumulative release percentage at 12 h reached up to 85%.Conclusion： SBE-β-CD can be used as a new osmotically active substance.The main mechanism of drug release from osmotic pump tablets is osmotic pump.